NCT06987474

Capella Scientia Development Study

Capella Scientia (SCDX) Development Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.

Detailed description

In this prospective, noninterventional, single-arm, unmasked, multicenter study, 4 different subject cohorts will be enrolled simultaneously to collect biometry and aberrometry data using Unity DX. This study will be conducted in India, Spain, and the Philippines.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Unity DX and SMARTCataract DX (SCDX) Biometer	Unity DX is a CE-marked, noninvasive, noncontact instrument that generates a 3D model of the eye using hyper parallel optical coherence tomography (HP OCT), aberrometry, and topography. The current version of SCDX software will be used in this study.
DEVICE	IOLMaster 700 Biometer	The IOLMaster 700 Biometer is a CE-marked, noninvasive, noncontact instrument that captures optical biometry. Data will be collected using standard clinical assessments.
DEVICE	Argos with Alcon Image Guidance Biometer	The Argos with Alcon Image Guidance biometer is a CE-marked, noninvasive, noncontact instrument that will capture optical biometry. Data will be collected using standard clinical assessments.

Timeline

• Start date: 2025-07-30
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-05-23
• Last updated: 2026-02-24

Locations

4 sites across 3 countries: India, Philippines, Spain